Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06101381
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-26
First Post:
2023-10-04
Brief Title:
CD19-directed CAR-T Cell Therapy for RR Acute Leukemia and Lymphoma
Sponsor:
University of Sao Paulo
Organization:
University of Sao Paulo
Study Overview
Official Title:
CD19-directed CAR-T Cell Therapy for Refractory or Relapsed Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma a Multicenter Phase III Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARTHEDRALL
Brief Summary:
The goal of this prospective multicentric single-arm phase III clinical trial is to evaluate the safety and efficacy of a novel CD19-directed CAR-T cell locally produced in an academic institution in Brazil in patients with refractory or relapsed acute lymphoblastic leukemia or non-Hodgkin lymphoma
Participants will receive a single intravenous infusion of an autologous academic anti-CD19 CAR-T cell and will be followed for 5 years
Participants will receive a single intravenous infusion of an autologous academic anti-CD19 CAR-T cell and will be followed for 5 years
Detailed Description:
Eighty-one patients with refractoryrelapsed RR B acute lymphoblastic leukemia B-ALL or non-Hodgkin lymphoma B-NHL will be included in this multicentric phase III clinical trial to evaluate the safety and efficacy of a novel academic CD19-directed CAR-T cell developed in Brazil
After the inclusion of the patient lymphocyte apheresis will be performed for lymphocyte collection followed by activation transduction with a lentiviral vector and expansion of produced CAR-T cells
The patient will be hospitalized and receive lymphodepleting chemotherapy started five days before CAR-T cells infusion with cyclophosphamide 300 mgm2day and fludarabine 30 mgm2day for three days On Day 0 CAR-T cells will be intravenously administered over 20-30 minutes The optimal CAR-T cell dose will be 17 to 54 x106 cellskg for ALL patients and 06 to 60 x 108 cells total dose for NHL patients but any dose higher than 02 x 106 cellskg for patients 50 Kg or 014 x 106 cellskg and 01 x 108 cells total dose for patients 50Kg and lower than the maximal 26 x 108 cells total dose will be infused depending on the obtained cellular product During and after infusion the patient will be monitored for signs and symptoms of toxicity and will remain hospitalized for at least two weeks All patients will receive anti-viral and anti-pneumocystis prophylaxis They will be monitored to evaluate treatment efficacy and acute and late toxicities for five years after infusion
After the inclusion of the patient lymphocyte apheresis will be performed for lymphocyte collection followed by activation transduction with a lentiviral vector and expansion of produced CAR-T cells
The patient will be hospitalized and receive lymphodepleting chemotherapy started five days before CAR-T cells infusion with cyclophosphamide 300 mgm2day and fludarabine 30 mgm2day for three days On Day 0 CAR-T cells will be intravenously administered over 20-30 minutes The optimal CAR-T cell dose will be 17 to 54 x106 cellskg for ALL patients and 06 to 60 x 108 cells total dose for NHL patients but any dose higher than 02 x 106 cellskg for patients 50 Kg or 014 x 106 cellskg and 01 x 108 cells total dose for patients 50Kg and lower than the maximal 26 x 108 cells total dose will be infused depending on the obtained cellular product During and after infusion the patient will be monitored for signs and symptoms of toxicity and will remain hospitalized for at least two weeks All patients will receive anti-viral and anti-pneumocystis prophylaxis They will be monitored to evaluate treatment efficacy and acute and late toxicities for five years after infusion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None